FDA 483 - Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy - September 15, 2022

During an FDA inspection on August 22-23, 2022, a facility was cited for deficiencies in the production of hazardous drugs, specifically regarding containment, segregation, and equipment handling.

The primary observation noted was the storage of non-sterile hazardous compounded drug products, including Tacrolimus 0.5 mg/ml Suspension and Hydroxyzine 100 mg/ml Suspension, in food-grade beverage pitchers. This practice raises concerns about potential leaching of hazardous drug substances into the containers, which could compromise the purity and potency of the drugs. Additionally, the adequacy of cleaning agents to deactivate and remove hazardous substances from these food-grade containers was questioned.

Furthermore, the inspection revealed inadequate containment and segregation of clean equipment and utensils, leading to potential cross-contamination. Specific examples included: * Uncovered clean mixing bowls stored on open shelves beneath a hood where hazardous Hydroquinone USP was weighed. * Uncovered clean mortars/pestles stored on open shelves below a workbench used for mixing and filling hazardous drugs. * A mortar and pestle from an open lower shelf being used during the production of Hydrocortisone/Hydroquinone/Kojic Acid/Tretinoin 1%/10%/3%/0.05% Cream. * Uncovered clean spatulas stored next to an open container used for soaking dirty equipment.

These observations indicate a lack of proper controls to prevent cross-contamination during the